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AZN

AstraZeneca

$32.29

0.03 (0.09%)

15:16
10/09/16
10/09
15:16
10/09/16
15:16

AstraZeneca gives Phase 3 data on fulvestrant, says talking to U.S. regulators

AstraZeneca announced data from the Phase III FALCON trial demonstrating "superior" median progression-free survival for fulvestrant 500mg compared to anastrozole 1mg in the 1st line treatment of postmenopausal women with locally-advanced or metastatic breast cancer, who have not had prior hormonal treatment for hormone receptor positive breast cancer. The primary endpoint was PFS and the FALCON trial enrolled 462 patients. The results, announced at the 2016 European Society for Medical Oncology Congress, show that the median PFS was 2.8 months longer with fulvestrant than anastrozole. The median PFS was 16.6 months in the fulvestrant arm, compared with 13.8 months in the anastrozole arm. The safety and tolerability profile was in line with current experience with fulvestrant and anastrozole. The most commonly reported adverse events in the fulvestrant and anastrozole arms were arthralgia in 16.7% vs 10.3%, hot flashes in 11.4% vs 10.3%, and nausea in 10.5% vs 10.3%. "Given the FALCON trial results, AstraZeneca is now in discussions with US regulatory authorities about a planned regulatory submission for a potential label extension," the company noted.

  • 16

    Nov

AZN AstraZeneca
$32.29

0.03 (0.09%)

09/13/16
EXAN
09/13/16
DOWNGRADE
EXAN
Neutral
AstraZeneca downgraded to Neutral from Outperform at Exane BNP Paribas
09/23/16
PIPR
09/23/16
INITIATION
PIPR
Overweight
AstraZeneca initiated with an Overweight at Piper Jaffray
Piper Jaffray analyst Richard Purkiss started AstraZeneca with an Overweight rating and GBP 60 price target.
09/23/16
09/23/16
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Morgan Stanley analyst Brian Nowak initiated Activision Blizzard (ATVI) and Electronic Arts (EA), both with Overweight ratings. The analyst is bullish on the digital gaming shift away from "units sold" to a business model based on users, engagement, and digital monetization. He sees digital in-game offerings resulting in recurring and growth user bases, increased per-game engagement, and further monetization opportunities. 2. AstraZeneca (AZN) and GlaxoSmithKline (GSK) both initiated with Overweight ratings by Piper Jaffray analyst Richard Purkiss. 3. Achillion (ACHN) initiated with an Outperform by Wedbush analyst Heather Behanna, who set a $13 price target on the shares. 4. Sysco (SYY) initiated with an Underweight at Barclays and $48 price target by analyst Karen Short. 5. Five Below (FIVE), Dollar Tree (DLTR) and Dollar General (DG) all initiated with Equal Weight ratings by Barclays analyst Karen Short. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/07/16
PIPR
10/07/16
NO CHANGE
PIPR
Neutral
Piper still sees Clovis' rucaparib getting broader indication than Lynparza
Piper Jaffray analyst Steven Breazzano said the rucaparib response rates in platinum resistant and platinum refractory patients of 25% and 0%, respectively, reported by Clovis Oncology (CLVS) are lower than some may have been expecting and "seemingly negative on the surface." However, he continues to believe rucaparib will be approved in BRCA patients who have received 2+ lines of therapy, which is an earlier and broader patient population than assigned to competitor AstraZeneca's (AZN) Lynparza, he tells investors. The ultimate market potential and key to success is the maintenance setting, for which TESARO's (TSRO) niraparib is still best-positioned, adds Breazzano, who keeps a Neutral rating on Clovis shares.

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